Craniofacial SurgeryNCT06970730
Accuracy of Virtual Surgical Planning and Patient Specific Implants in Craniomaxillofacial Reconstruction
A study testing virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction in people with Craniofacial Surgery and Virtual Surgical Planning, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
The sample will consist of 10 patients who will need reconstruction of craniomaxillofacial deformities and defects. The patients will be operated in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt. Read more about this study
- Who is it for?
- Ages 10 to 47 years
- Conditions the study is for
- Craniofacial Surgery, Virtual Surgical Planning
- What is being tested?
- virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 47 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Reconstruction of craniofacial, midface, and mandibular bony defects and deformities secondary to:
- Trauma.
- Tumor resection (either by immediate or delayed reconstruction).
- Complex congenital and dentofacial deformities.
Who cannot join
- Patients with special needs.
- Medically compromised patients who are not fit for surgery.
- Irradiated patients.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203
About this study
Official title: Evaluation of Accuracy of Virtual Surgical Planning and Patient Specific Implants in Craniomaxillofacial Reconstruction (Clinical Trial)
The sample will consist of 10 patients who will need reconstruction of craniomaxillofacial deformities and defects. The patients will be operated in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt. All patients will be assessed clinically and radiographically using computed tomography (CT) then virtual surgical planning and custom made patient specific implant will be manufactured. Post-operative clinical evaluation will be done and radiographic evaluation of all patients will be done by CT scan
Read the detailed description
The primary outcome of the study is to evaluate the accuracy of virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction based on radiographic measurements to calculate the angulation deviations of anatomic landmarks between the pre-operative virtual plan and the post-operative actual surgical outcome.
The secondary outcome is long term follow up of the patients clinically and radiographically regarding aesthetics, quality of life and post-operative complications.
- Conditions
- Craniofacial Surgery, Virtual Surgical Planning
- Being tested
- virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual surgical planning and patient specific implants in craniomaxillofacial reconstructionProcedure or surgery
Image acquisition by computed tomography (CT slice thickness 1 mm or less) + laser scanning of patient models. Virtual surgical planning and design of patient specific implants. Patient specific implants manufacturing (milling technique) and 3D printing of surgical guides and fit models.
| Study group | Role | What they receive |
|---|---|---|
| virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction. | Experimental | Not described Receives: Procedure: virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance deviation
the accuracy of reconstruction, defined as linear deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans
Measured: Immediate post operative
Angular deviation
the accuracy of reconstruction, defined as angulation deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans
Measured: Immediate post operative
Secondary outcomes (2)
Change in post operative aesthetic results of surgery
aesthetic scale from zero to 5
- 5 points - changes are not visually noticeable.
- 4 points - changes in appearance are barely noticeable and do not affect the patient's quality of life.
- 3 points - aesthetic deficit that does not require surgical correction.
- 2 points - aesthetic defects require minor surgical corrections in the postoperative period.
- 1 point - significant aesthetic defects require serious (often multi-stage surgical correction).
- 0 points - the presence of severe aesthetic defects that cannot be eliminated.
Measured: 1 week, 4 weeks, 8 weeks, and 6 months
change in Quality of Life (QOL)
Scores as follow 0 = much better.
- = better.
- = the same.
- = worse.
- = much worse
Measured: 1 week, 4 weeks, 8 weeks, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start1 Feb 2021
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06970730
- Sponsor's protocol ID
- 644-08/2021
- Status last verified
- May 2025
- First submitted
- 27 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Accuracy of Virtual Surgical Planning and Patient Specific Implants in Craniomaxillofacial Reconstruction (Clinical Trial)
- ClinicalTrials.gov ID
- NCT06970730
- Acronym / sponsor ID
- 644-08/2021
- Conditions
- Craniofacial Surgery, Virtual Surgical Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The sample will consist of 10 patients who will need reconstruction of craniomaxillofacial deformities and defects. The patients will be operated in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt. All patients will be assessed clinically and radiographically using computed tomography (CT) then virtual surgical planning and custom made patient specific implant will be manufactured. Post-operative clinical evaluation will be done and radiographic evaluation of all patients will be done by CT scan
Detailed description
The primary outcome of the study is to evaluate the accuracy of virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction based on radiographic measurements to calculate the angulation deviations of anatomic landmarks between the pre-operative virtual plan and the post-operative actual surgical outcome.
The secondary outcome is long term follow up of the patients clinically and radiographically regarding aesthetics, quality of life and post-operative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction. | Experimental | Procedure: virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction |
Who may qualify
- Ages
- 10 to 47 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Reconstruction of craniofacial, midface, and mandibular bony defects and deformities secondary to:
- Trauma.
- Tumor resection (either by immediate or delayed reconstruction).
- Complex congenital and dentofacial deformities.
Key exclusion criteria (3 listed)
- Patients with special needs.
- Medically compromised patients who are not fit for surgery.
- Irradiated patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual surgical planning and patient specific implants in craniomaxillofacial reconstructionImage acquisition by computed tomography (CT slice thickness 1 mm or less) + laser scanning of patient models. Virtual surgical planning and design of patient specific implants. Patient specific implants manufacturing (milling technique) and 3D printing of surgical guides and fit models. | Procedure or surgery | virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction. |
Primary outcome
Distance deviation
Time frame: Immediate post operative
the accuracy of reconstruction, defined as linear deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans
Angular deviation
Time frame: Immediate post operative
the accuracy of reconstruction, defined as angulation deviations of anatomic landmarks between the virtual plan and the actual surgical outcome using CT scans
2 secondary outcomes
Change in post operative aesthetic results of surgery
Time frame: 1 week, 4 weeks, 8 weeks, and 6 months
change in Quality of Life (QOL)
Time frame: 1 week, 4 weeks, 8 weeks, and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction in people with Craniofacial Surgery and Virtual Surgical Planning, run by Hams Hamed Abdelrahman at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distance deviation (time frame: Immediate post operative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.